Establishing the Right Foundation for Patient Safety in 2025

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Digital transformation was a common theme at conferences like World Drug Safety Congress and Veeva R&D Summit. But what does a shift to digital in drug safety mean? How can companies begin modernization initiatives with growing safety data volumes and fewer resources?

Although moving away from legacy systems can feel overwhelming and complex, at the heart of it, companies want simplification. With a unified, connected platform, safety teams can simplify and standardize their systems landscape and lay a foundation for advanced automation. The improvements can drive productivity and reduce costs, delivering an environment for innovation.

“We’re building a reliable data foundation to ensure high data quality and fewer handoffs,” says an associate vice president of pharmacovigilance (PV) operations at a top 20 biopharma currently consolidating its PV system landscape. “By simplifying our landscape, we will reduce manual effort and optimize our resources to deliver greater patient value.”

Large biopharmas and fast-growing biotechs are bringing together their safety data and documents for reduced resource effort, time savings, and simpler PV processes. Three leaders share their experiences advancing their pharmacovigilance operations.

Simplifying systems for streamlined case processing

An associate vice president of PV operations’ is working toward simplifying her organization’s PV landscape, reducing their existing 30 systems by 50%. “With over 30 systems, you can imagine the integrations, customizations, and upkeep it takes to keep them running,” she said. The company currently has two safety databases that aren’t connected—one used globally and one for Japan. “Once we consolidate the two databases, we anticipate reduced overhead and costs,” she says.

A top 20 biopharma that is further in its modernization effort has retired 25 systems and unified them on a single cloud safety platform. By consolidating its systems, the company has a foundation to fuel long-term strategic initiatives that drive innovation.

“We’re focused on low-touch, non-serious case processing,” said the company’s technology practice lead. Their PV team just completed the first steps of its low-touch case process program using its modern safety system, leveraging advanced capabilities to process approximately 800 cases a month. Their goal is to reach 100,000 cases a month by the end of 2025.

Accelerating clinical trial timelines and reducing costs

After bringing its operations onto a single platform, Inhibrx, a clinical-stage biopharma, has reduced its study activation timeline by 90 days. The modernization effort helped the company bring its functions in-house and connect functions, including clinical data and PV. Compared to a traditional outsourced CRO model, Inhibrx anticipates an in-house model will deliver significant savings on clinical trial costs.

“The goal is to develop life-saving medications for patients faster. That comes down to saving time and money,” said Bonne Adams, vice president of operations at Inhibrx. “When you get a study up and running quicker, your product gets out into the market sooner.”

The associate vice president of PV operations at a top 20 biopharma is also working to enable better collaboration and communication between functional areas. “PV processes touch so many different departments,” she explains. “Better connectivity will enable automated, seamless data flow with our manufacturing, medical affairs, regulatory, and clinical colleagues.”

Prioritizing clean and accurate safety data to mitigate risk

With a simplified and unified safety platform, Adams says the benefits include risk mitigation and improved data quality. “When data is entered multiple times into different systems, it introduces a high risk of human error. Reconciling that data can come at a very high cost,” she explains.

“Allowing safety and clinical operations teams to work better together ensures we have distributed our cases to the right people and proves that they received them,” adds Adams. “Connecting safety and regulatory guarantees that the product information is correct because it flows seamlessly. Everybody has the same information, and it all matches up.”

As Inhibrx continues establishing a strong data foundation, Adams hopes to eliminate redundancies across the company’s systems landscape. "I wanted to create an environment where the same piece of data is only entered once in one place and flows through all of our systems to break down those redundancies.”

Adopting new ways of working to drive effectiveness

By unifying their safety systems and prioritizing data accuracy, companies can establish a foundation for modern, advance PV. For companies beginning their modernization initiatives, Adams recommends to remain open-minded to adopting new ways of working. “Being willing to adopt tech and taking advantage of new solutions is crucial,” she says. “Our partnership with Veeva allows us to stay at the forefront of technological advancements in the industry. We are now streamlining our operations and improving efficiency.”

The technology practice lead at another top 20 biopharma echoes Adams’ sentiments. “Building a strong, collaborative relationship with a trusted safety software vendor is critical,” she says. “We're not just implementing a new solution to fit our current processes, we're challenging our organization to think differently about how to leverage our system functionality to work better and more efficiently.”

Mike Kruczek, senior director, Veeva Vault Safety strategy